Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pulse Rate and Breathing Rate
- Sponsor
- Nuralogix Corporation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Breathing rate accuracy validation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate
- •Participant must be 18 to 81 years of age (≥ 18 age to \< 82)
- •Participant must be willing and able to comply with study procedures and duration
- •Participants or legally authorized representative must be able to read or write in English
Exclusion Criteria
- •Participants who refuse or are unable to provide to sign an informed written consent for study
- •Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
- •Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
- •Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported)
- •Other known health condition, should be considered upon disclosure in health assessment form
Outcomes
Primary Outcomes
Breathing rate accuracy validation
Time Frame: 1-2 hours
The purpose of this study is to conduct a Breathing Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually scoring the collected waveform for data analysis
Pulse rate accuracy validation
Time Frame: 1-2 hours
This study will also assess the pulse rate measurements of the NuraLogix AMC-SDK for comparison to a standard ECG (GE Datex-Ohmeda) derived heart rate reference.
Secondary Outcomes
- Pulse rate simulation(1-2 hours)